Annual Estimates of Influenza Vaccine Effectiveness and Evaluation of Immune Response in a Wisconsin Population

威斯康星州人群流感疫苗有效性的年度估计和免疫反应评估

• 批准号: 10179274
• 负责人: EDWARD BELONGIA
• 金额: $ 50万
• 依托单位: MARSHFIELD CLINIC RESEARCH FOUNDATION
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-01 至 2020-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10179274
• 关键词: Annual; Estimates; Influenza; Vaccine; Effectiveness

Project Summary/Abstract - Core and Additional Components Influenza, an important cause of morbidity and mortality, and influenza vaccination are key components of influenza prevention. The effectiveness of influenza vaccine varies from year to year, and it can vary by virus subtype, age group, product type, population characteristics, and antigenic match. Annual assessment of clinical vaccine effectiveness is therefore needed to evaluate the impact of current vaccine recommendations and policies, understand the relationship between antigenic changes in viruses and clinical protection, and prepare for vaccine assessment during a pandemic. Interim, mid-season estimates of vaccine effectiveness are useful for public health agencies and physicians. The first Aim of the project is to estimate the effectiveness of influenza vaccine for preventing medically-attended, laboratory confirmed influenza illness in a defined population cohort of adults and children. Patients who seek outpatient care for acute respiratory illness will be recruited during the influenza season. Patients with cough and illness duration ≤7 days will be eligible. After informed consent, nose and throat swabs will be tested for influenza A and B using a nucleic acid amplification test (RT- PCR). Samples will be provided to CDC for antigenic characterization and other tests as appropriate. Influenza immunization status will be determined by a validated immunization registry. Vaccine effectiveness will be calculated using the test negative design where cases include participants with RT-PCR confirmed influenza and controls include study participants with noninfluenza respiratory illness (negative RT-PCR). Data will be provided to CDC for combined analyses with other participating sites, including mid-season data for interim analysis of effectiveness. When possible, separate estimates of vaccine effectiveness will be calculated for different age groups, influenza subtypes, and for different vaccine products. The second Aim is to evaluate the disease burden due to RSV during the last three seasons of the project. Participant samples will be tested for RSV using RT-PCR, and the incidence of medically attended RSV will be estimated. The third Aim is to serve as an emergency response resource for CDC pandemic studies of vaccination and antivirals. This will include pilot studies to prepare for a pandemic.

项目摘要/摘要 - 核心和其他组件 流感是发病率和死亡率的重要原因，以及流感疫苗接种是关键 预防影响力的组成部分。从一年到一年 一年，它可能因病毒亚型，年龄段，产品类型，人口特征和 抗原匹配。因此，需要对临床疫苗有效性的年度评估 评估当前疫苗建议和政策的影响，了解 病毒和临床保护的抗原变化之间的关系，并准备 大流行期间的疫苗评估。疫苗有效性的临时，季节中期估计 对公共卫生机构和医师有用。该项目的第一个目的是估计 实验室证实，影响力疫苗预防医学上的有效性 在定义的成年人和儿童人群中的影响力疾病。寻求的患者 在影响力季节，将招募针对急性呼吸系统疾病的门诊护理。 咳嗽和疾病持续时间≤7天的患者符合条件。知情同意后，鼻子 将使用核酸扩增测试（RT- PCR）。将向CDC提供样品，以进行抗原表征和其他测试作为 合适的。流感免疫抑制状态将由经过验证的免疫抑制确定 注册表。疫苗有效性将使用测试负面设计计算 包括具有RT-PCR确认的影响力和对照组的参与者包括研究参与者 非influenza呼吸道疾病（RT-PCR阴性）。数据将提供给CDC 结合分析与其他参与站点，包括用于临时分析的季节数据 有效性。如果可能，将计算单独的疫苗有效性估计值 对于不同年龄组，影响力亚型和不同的疫苗产品。第二个目标 是在项目的最后三个季节中评估由于RSV引起的疾病烧伤。 参与者样本将使用RT-PCR测试RSV，并在医学上进行。 参加的RSV将被估算。第三个目的是作为紧急响应资源 用于疫苗接种和抗病毒药的CDC大流行研究。这将包括准备准备 大流行。